Автор: Wang Название: Biological Drug Products: Development and Strategies ISBN: 1118148894 ISBN-13(EAN): 9781118148891 Издательство: Wiley Рейтинг: Цена: 24544.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book overviews the fundamental aspects, challenges, and strategies for developing a variety of biological drugs -- a large and growing segment of the pharmaceutical industry. Contributing authors discuss the development process, safety and clinical assessments, manufacturing, regulatory and intellectual property issues.
Автор: Maik W. Jornitz; O.W. Reif; M.W. Jornitz; R.V. Lev Название: Sterile Filtration ISBN: 354028625X ISBN-13(EAN): 9783540286257 Издательство: Springer Рейтинг: Цена: 34937.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 1 R. Levy: Types of Filtration.- 2 T. Meltzer: Modus of Filtration.- 3 O.W. Reif: Microfiltration Membranes: Characteristics and Manufacturing.- 4 M. Jornitz: Filter Constructions and Design.- 5 R. Madsen: Filter Validation.- 6 M. Jornitz: Integrity Testing.-
Автор: Parag Kolhe; Mrinal Shah; Nitin Rathore Название: Sterile Product Development ISBN: 1461479770 ISBN-13(EAN): 9781461479772 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.
Автор: Jornitz, Maik W. Название: Sterile Filtration ISBN: 0824702824 ISBN-13(EAN): 9780824702823 Издательство: Taylor&Francis Рейтинг: Цена: 33686.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Odum, Jeffrey N. Название: Sterile Product Facility Design and Project Management ISBN: 0367394405 ISBN-13(EAN): 9780367394400 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices.
Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.
Автор: Hout, Sam A. Название: Sterile manufacturing ISBN: 0367754355 ISBN-13(EAN): 9780367754358 Издательство: Taylor&Francis Рейтинг: Цена: 12554.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Автор: Riley, Christopher M. Название: Riley - Spec of Drug Substances and Products, 2e ISBN: 0081028245 ISBN-13(EAN): 9780081028247 Издательство: Elsevier Science Рейтинг: Цена: 28633.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered-or not substantially covered-in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.
The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
Written by subject-matter experts involved in the development and application of the guidelines
Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Автор: Hout, Sam A. Название: Manufacturing of quality oral drug products ISBN: 1032124733 ISBN-13(EAN): 9781032124735 Издательство: Taylor&Francis Рейтинг: Цена: 12554.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.
Автор: Stegemann Название: Developing Drug Products in an Aging Society ISBN: 3319430971 ISBN-13(EAN): 9783319430973 Издательство: Springer Рейтинг: Цена: 34937.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.
Автор: Jameel Feroz, Skoug John W., Nesbitt Robert R. Название: Development of Biopharmaceutical Drug-Device Products ISBN: 3030314170 ISBN-13(EAN): 9783030314170 Издательство: Springer Цена: 32142.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Foreword Juergen M. Zeidler, PhD and Ramakrishna Venugopalan, PhD (AbbVie) 0Part 1: Drug Product Development1 Monoclonal Antibodies: Structure, Physicochemical Stability and Protein Engineering Brittney Mills, Ehab Moussa and Feroz Jameel (AbbVie) 12 Challenges and Considerations in the Design of Antibody Drug Conjugates Feroz Jameel, Brittney Mills, Ehab Moussa and Vikram Sisodiya, Anthony Haight and Tony Cano (AbbVie) 218 Enabling Drug-Device Combination Products: Device-ability in Protein Therapeutics Bernardo Perez-Ramirez, PhD, Jon Kingsbury, and Jifeng Zhang (Sanofi-Genzyme) 33 Production Strategies and Challenges with IgG-based Bispecific Antibody Formats Chen Gu and Diego Ellerman (Genentech) 44 Lessons Learned in Understanding Dual-variable Domain Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates W. Blaine Stine, Dana Filoti and Tariq Ghayur (AbbVie) 56 High-Throughput Conformational and Colloidal Stability Screening of Biologic Molecules Peter M. Ihnat, Jun Zhang, Jianwen Xu and Kan Wu (AbbVie) 68 An Empirical Phase Diagram/High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals Russell Middaugh, Yangje Wei, Sangeet Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas Larson, Gang Hu, Eric Deeds (University of Kansas) 79 Biophysical Characterization and the Development of Therapeutic Proteins Russell Middaugh, Yangje Wei, Nicholas Larson, Gang Hu, Prashant Kumar (University of Kansas) 85 Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic Development Richard Rogers, PhD (Just Biotherapeutics) 97 Analytical Methods for Antibody Drug Conjugate Characterization Stephanie Fischmann, Julie Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach and Gregory Webster (AbbVie) 10 Part 1: Drug Product Development, (continued): Chapter: Title Authors New #15 Particles in Liquid Drug Products: Causes, Characterization and Strategy Anacelia Rнos Quiroz, Miguel Saggu, Jan Olaf Stracke & Jamie Moore (Roche & Genentech) 1110 Strategies in the Development of Formulations for Antibody based Therapeutics Feroz Jameel, Ehab Moussa, Brittney Mills and Peter Ihnat (AbbVie) 1211 Formulation, Drug Product Process and Delivery Considerations for Bi-specific Antibody-Based Molecules Krishnan Sampathkumar (Macrogenics) Status TBD 1312 Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models Michael Siedler, Sabine Eichling, Martin Huelsmeyer, and Jonas Angstenberger (AbbVie) 1413 Practical considerations in high concentration formulation development for monoclonal antibody drug products Dingjiang (Dean) Liu, Quingyan Hu, Bowen Jiang, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem (Regeneron) 1514 Drug Product Formulation Robustness Criteria for a MAb in a Pre-filled Syringe Karen Rutherford, Greg Downing and Alvattam Sreedhara (Genentech) 1616 Development of Robust Lyophilization Process for Therapeutic Proteins: A case Study Ehab Moussa, Tong Zhu and Feroz Jameel (AbbVie) 1719 Scale-Down Models for Robust Biologics Drug Product Process Development Smeet Deshmukh, Maria O. Ogunyankin (Merck) 1826 Design of Clinical in use Studies Supriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, Vivek Garripelli, Hanmin Dong, Stephanie Sawilla, Bhargav Patel, and Rudolf Schroeder, (AbbVie) 1920 Design of a Bulk Freeze-Thaw Process for Biologicals Feroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie) 2021 Freeze-Thaw Process Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill Volumes Alina A. Alexeenko (Purdue Univ.), Laura Mozdzen, Sherwin Shang, Michelle Long, Grace Kim
Автор: Thangaraj Parimelazhagan Название: Pharmacological Assays of Plant-Based Natural Products ISBN: 3319268104 ISBN-13(EAN): 9783319268101 Издательство: Springer Рейтинг: Цена: 19564.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: After a detailed in vitro investigation including nutritional and anti-nutritional analyses, medicinal properties were tested with various in vivo models for anti-inflammatory, analgesic, anti-pyretic, anticancer and anti-diabetic properties, as well as wound healing, neurodegenerative diseases, etc.
Автор: Sven Stegemann Название: Developing Drug Products in an Aging Society ISBN: 3319827383 ISBN-13(EAN): 9783319827384 Издательство: Springer Рейтинг: Цена: 25155.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.
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